New labeling rules for minerals

Related tags Vitamin d Hypertension

The FDA has clamped down on the labeling of OTC drugs publishing
new rules that require content and warning labeling for levels of
calcium, magnesium, sodium, or potassium that might be harmful to
people with certain underlying medical conditions.

The new labeling laws - published in the Federal Register​ - will be effective from April 23, 2004 with full compliance by September 25, 2005, said the Food and Drug Administration (FDA).

"These new warnings provide an extra level of safety for people who may be especially sensitive to these commonly used OTC ingredients,"​ said acting FDA Commissioner Lester M. Crawford. Although these ingredients can generally be used safely and provide benefit to many consumers, people with conditions that put them at risk of side effects need to be aware of the presence of these ingredients, he added.

Under the new rules, the labeling of oral Over-The-Counter drugs containing sodium, calcium, magnesium, or potassium must state the amount of a particular ingredient in each dose if they contain: 5 milligrams (mg) or more of sodium in a single dose, 20 mg or more of calcium in a single dose, 8 mg or more of magnesium in a single dose, or 5 mg or more of potassium in a single dose.

The new rules also require new warnings on the label to alert people who are on sodium, calcium, magnesium, or potassium-restricted diets to consult their doctors before using products for oral ingestion.

The motivation behind the new rules is based on current scienc that suggests sodium may be related to high blood pressure and is a concern for individuals with congestive heart failure. In people with kidney disease, blood levels of calcium, magnesium, and potassium can reach potentially dangerous levels due to their decreased elimination, and people with kidney stones need to carefully monitor their calcium intake.

In the same week the FDA warned consumers about a recall by Aloe Commodities of 1600 bottles of Solutions IE Ageless Formula II, Lot numbers P2207 and P2221 because they contain a massively higher-than-labeled level of vitamin D3. Approximately 188,640 International Units (IU) are present in each serving size of 6 capsules instead of the much lower intended level of 400 IU. The product is distributed by Solutions International.

The FDA urged consumers to seek medical attention if they have been taking the supplements and have symptoms of vitamin D toxicity such as weakness, tiredness, headache, flu-like symptoms, nausea and diarrhea.

The alarm was raised after it was discovered that the product contained more than the labeled amount of vitamin D due to an error in manufacturing. The 750 mg dietary supplement was packed 180 capsules per bottle and coded lot number P2207 or P2221. The lot coding can be found on the bottom of the bottle.

Related topics Minerals

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